SMMT · SUMMIT THERAPEUT Q2 FY2026 earnings call record财报电话会记录

“In this most recent analysis, with a data cutoff in June 2026, Western patients increased their time on study, reaching a median follow-up of over 23 months.”

“A hazard ratio of 0.76 was observed in both the total population as well as the regional Western data.”

“Considering the safety and efficacy profile of the current FDA-approved options for patients in this setting, none of which have demonstrated a statistically significant OS benefit, as well as the continued positive regionally consistent data of this phase III multi-regional study and discussions with key opinion leaders and physicians who have administered ivonescimab to patients, we believe that ivonescimab is a potential treatment option with favorable benefit risk profile.”

“Additionally, we have over 65 ISTs that we intend to support in various stages of development.”

“HARMONi-2, conducted in China, which was the first time a phase III clinical trial has shown a statistically significant improvement in progression-free survival, directly replaced a PD-1 inhibitor in head-to-head setting, reported an overall survival hazard ratio of 0.78 at just 39% data maturity.”

“Turning to slide nine and looking to the existing next steps for ivonescimab, our global phase III HARMONi-3 all-comers trial evaluating ivonescimab with chemo in frontline non-small cell lung cancer has completed enrollment in both the squamous and non-squamous cohorts.”

“Importantly, we expect to have another interim look at OS in first half of 2027, which will have additional follow-up time, something we continue to note as an important factor in showing the value of ivonescimab in these clinical studies.”

“The agency has provided a target PDUFA date of November 14 of this year.”

“Again, recall the fact that with 22, 23 months of overall survival or follow-up time in an overall survival analysis, we've shown meaningful data in HARMONi-6 in China, and then the global HARMONi data; the Western patients with meaningful follow-up time showed that benefit.”

“We saw the 0.79, 0.78 in the follow-up shortly thereafter the primary, and then the 0.76 that was announced yesterday.”

“I have a question on alpha spending and its potential impact on HARMONi-3 squamous OS.”

“A 34% reduction in the risk of death is amazing over a PD-1.”